[Federal Register Volume 78, Number 179 (Monday, September 16, 2013)]
[Proposed Rules]
[Pages 56839-56841]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-22464]

Proposed Rules
                                                Federal Register

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.


Federal Register / Vol. 78, No. 179 / Monday, September 16, 2013 / 
Proposed Rules

[[Page 56839]]


10 CFR Part 32

[Docket No. PRM-32-7; NRC-2012-0127]

Compatibility of Generally Licensed and Exempt Devices

AGENCY: Nuclear Regulatory Commission.

ACTION: Petition for rulemaking; denial.


SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is denying a 
petition for rulemaking (PRM), dated May 7, 2012, submitted by Mr. Sean 
Chapel (the petitioner) on behalf of the Association of Device 
Distributors and Manufacturers (ADDM). The petition was docketed by the 
NRC on May 24, 2012, and was assigned Docket No. PRM-32-7. The 
petitioner requested that the NRC create a new regulation for exempt 
devices similar to the NRC's regulations for generally licensed 
devices. The petitioner also requested that the NRC change the 
Agreement State compatibility designation of the regulations applicable 
to generally licensed devices that are specified in Sec.  31.6 of Title 
10 of the Code of Federal Regulations (10 CFR) from ``C'' to ``B''. The 
NRC is denying the petition because the petitioner failed to present 
any significant new information or arguments that would support the 
requested changes, nor has he demonstrated a need for a new provision 
for exempt devices.

DATES: The docket for the petition for rulemaking, PRM-32-7, is closed 
on September 16, 2013.

ADDRESSES: Please refer to Docket ID NRC-2012-0127 when contacting the 
NRC about the availability of information for this petition. You may 
access publicly-available information related to this petition by any 
of the following methods:
     Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2012-0127. Address 
questions about NRC dockets to Carol Gallagher; telephone: 301-287-
3422; email: [email protected]. For technical questions, contact 
the individual listed in the FOR FURTHER INFORMATION CONTACT section of 
this document.
     NRC's Agencywide Documents Access and Management System 
(ADAMS): You may access publicly available documents online in the NRC 
Library at http://www.nrc.gov/reading-rm/adams.html. To begin the 
search, select ``ADAMS Public Documents'' and then select ``Begin Web-
based ADAMS Search.'' For problems with ADAMS, please contact the NRC's 
Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-
4737, or by email to [email protected]. The ADAMS accession number 
for each document referenced in this document (if that document is 
available in ADAMS) is provided the first time that a document is 
referenced. The petition, PRM-32-7, is available in ADAMS under 
Accession No. ML12146A083.
     NRC's PDR: You may examine and purchase copies of public 
documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 
Rockville Pike, Rockville, Maryland 20852.

FOR FURTHER INFORMATION CONTACT: Solomon Sahle, Office of Federal and 
State Materials and Environmental Management Program, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-
3781, email: [email protected].


I. The Petition

    Section 2.802 of 10 CFR, ``Petition for rulemaking,'' provides an 
opportunity for any interested person to petition the Commission to 
issue, amend, or rescind any regulation. On May 7, 2012, the NRC 
received a PRM from Mr. Sean Chapel on behalf of the ADDM. The PRM 
contained two requests.
    The petitioner's first request was ``that language similar to 10 
CFR 31.6 be included in section 10 CFR [part] 32 to include the 
servicing of exempt devices, since these are within the jurisdiction of 
the NRC.'' The petitioner further asserted that ``[i]t does not make 
sense that generally licensed devices can be serviced without filing 
for reciprocity, but exempt devices, which have a lower radiation dose 
potential, [cannot] be.'' The petitioner suggested the following 
language for 10 CFR part 32:

    Any person who holds a specific license issued by an Agreement 
State authorizing the holder to manufacture, install or service a 
device described in [Sec. Sec.  ] 32.14, 32.22, or 32.26 within such 
Agreement State is hereby granted a general license to install and 
service such device in any non-Agreement State and a general license 
to install and service such device in offshore waters, as defined in 
Sec.  150.3(f) of this chapter:, [p]rovided [t]hat:
    (a) Reserved[.]
    (b) The device has been manufactured, labeled, installed and 
serviced in accordance with the provisions of the specific license 
issued to such person by the Agreement State.
    (c) Such person assures that any labels required to be affixed 
to the device under regulations of the Agreement State which 
licensed manufacture of the device bear a statement that removal of 
the label is prohibited.

    The petitioner's second request was that the NRC change the 
compatibility designation of 10 CFR 31.6, ``General license to install 
devices generally licensed in Sec.  31.5,'' from ``C'' to ``B.'' The 
petitioner's basis for the request for compatibility change was that 
``inconsistent application of individual Agreement State regulations 
and policies places an unreasonable burden on licensees to maintain 
compliance.'' Further, the petitioner stated that in 2000, the NRC 
changed the compatibility of 10 CFR 31.6 from ``C'' to ``B'' ``in 
acknowledgement of the problems caused by incompatible State 
reciprocity regulations.''
    The petitioner stated that ``[t]he Commission voted to decrease the 
compatibility in December 2010, stating that they thought it 
appropriate for Agreement States to regulate devices in their 
jurisdiction as they saw fit.'' The petitioner asserted that ``[i]n the 
Commission ruling, there is no evidence that they fully reviewed the 
original decision in 2000 to increase the compatibility rating.''
    The petitioner stated that ``reciprocity regulations must be 
standardized at the national level'' to avoid the chaos that ``would be 
caused if each state had different regulations for occupational 
radiation doses, nuclear power plant operation, or high and low level 
radioactive waste.'' The petitioner asserted that ``[t]his is the type 
of disorder that reciprocity applicants are forced to endure on a daily 
basis.'' The petitioner stated that ``[t]he NRC should enforce these 
requirements as part of the

[[Page 56840]]

IMPEP [Integrated Materials Performance Evaluation Program] review 
process.'' The petitioner further stated ``that there are several 
Agreement States which have adopted 10 CFR 31.6, but do not implement 
the regulations as they are written, and still require reciprocity to 
be filed.'' In reference to the change in compatibility, the petitioner 
is ``not asking that the regulations be re-written, only that they be 
enforced as written.''
    In support of the second request, the petitioner cited a PRM dated 
June 27, 2005 (ADAMS Accession No. ML051940187), from the Organization 
of Agreement States (OAS), which requested that the compatibility of 10 
CFR 31.6 be revised from ``C'' to ``B.'' The petitioner also noted that 
the OAS petition ``stated that the reason for changing the 
compatibility of 10 CFR 31.6 was to assist the tracking and movement of 
companies and individuals that service these devices.'' The NRC staff 
asked the petitioner, by telephone, to clarify that the reference was 
to an OAS PRM requesting that the compatibility of 10 CFR 31.6 be 
revised from ``B'' to ``C,'' and if so, to resubmit a letter correcting 
his PRM. By letter dated August 3, 2012 (ADAMS Accession No. 
ML12219A085), the petitioner corrected his reference to the OAS PRM.

II. Discussion

Reciprocity for Exempt Devices

    Section 31.6 of 10 CFR provides a general license to persons 
holding a specific license issued by an Agreement State that authorizes 
manufacture, installation, or servicing of a device described in 10 CFR 
31.5 to install and service these devices in any non-Agreement State 
and in offshore waters. The NRC adopted this regulation in 1962 
(originally in 10 CFR 30.21(c)(6)) at the same time 10 CFR part 150, 
``Exemptions and Continued Regulatory Authority in Agreement States and 
in Offshore Waters Under Section 274,'' was issued as part of 
implementing the Agreement State program.
    In accordance with 10 CFR 150.15(a)(6), only the NRC can issue 
licenses for the manufacture, processing, or production of any 
equipment, device, commodity, or other product containing source 
material or byproduct material whose subsequent possession, use, 
transfer, and disposal by all other persons are exempted from licensing 
and regulatory requirements. Therefore, the Agreement States do not 
issue licenses to manufacture, install, or service exempt devices. 
Further, servicing exempt devices does not require a license. Any 
refurbishing not covered by the exemption, such as replacement of a 
source in a device, would require an NRC license and/or an Agreement 
State license. Therefore, a general license is not required to install 
or service exempt devices, and the petitioner's requested change to the 
regulations is not needed.

Compatibility of 10 CFR 31.6

    On January 25, 2012, the NRC published a Federal Register notice 
(FRN) (77 FR 3640) to withdraw a proposed rule and to close PRM-31-5 
(NRC-2005-0018; NRC-2008-0272). PRM-31-5 requested that the NRC amend 
its regulations to strengthen the regulation of radioactive materials 
by requiring a specific license for higher-activity devices that are 
currently available under a general license and by changing the 
compatibility designation of 10 CFR 31.6 from category ``B'' to 
category ``C.'' In this FRN, the NRC also addressed a related request 
filed by the Florida Department of Health, Bureau of Radiation Control, 
in conjunction with the OAS petition to change the compatibility 
category of a certain part of the applicable regulations from category 
``B'' to category ``C.''
    In response to PRM-31-5, the NRC developed a proposed rule that 
would have limited the quantity of byproduct material contained in a 
generally licensed device to below one-tenth of the International 
Atomic Energy Agency Category 3 thresholds. It would also have changed 
the compatibility of the applicable regulations.
    The compatibility change requested in PRM-31-5 was filed in 
response to the 2000 general license rule (65 FR 79162; December 18, 
2000), which designated the requirements in 10 CFR 31.5 and 10 CFR 31.6 
as compatibility category ``B.'' The general license rule adopted 
compatibility ``B'' for these regulations because the Commission was 
concerned that essentially identical regulations were needed to ensure 
reciprocal recognition of licenses and licensing requirements among 
Agreement States and the NRC. After evaluating the post-2000 general 
license regulations in response to PRM-31-5, the NRC reassessed its 
position. The NRC found that since 2000, Agreement States took a 
variety of actions that were not consistent with the rule, despite its 
designation as compatibility category ``B.'' Many Agreement States 
adopted stricter regulations of generally licensed devices, including 
registration with annual reporting requirements and periodic 
inspection; expanded registration of more types of generally licensed 
devices; specific licensing of certain generally licensed devices; and 
specific licensing of all generally licensed devices currently 
registered by the NRC. However, the NRC did not observe any 
transboundary problems from these different practices that would have 
supported the continued use of compatibility ``B'' for 10 CFR 31.5 and 
31.6. Further, complexity and cost are not aspects of determining 
significant transboundary health and safety impacts under the 
Commission's 1997 Policy Statement on Adequacy and Compatibility of 
Agreement State Programs (62 FR 46517; September 3, 1997). Therefore, 
the NRC believed it was appropriate to change the compatibility 
category from ``B'' to ``C'' for 10 CFR 31.5 and 10 CFR 31.6. This 
action allowed many Agreement States to continue the practices they had 
already implemented and to take additional steps they deem appropriate 
based on local circumstances, including retaining the use of tools to 
track the location and movement of devices, manufacturers, and service 
providers within the State; addressing issues specific to their 
jurisdictions; continuing programs that have proven beneficial; and 
adopting requirements based on their specific circumstances and needs.
    After further review, the Commission addressed the compatibility-
related issues raised in PRM-31-5. Although the Commission disapproved 
publication of the final rule and withdrew the proposed rule, it 
approved the change in compatibility for 10 CFR 31.5 and 10 CFR 31.6. 
The Commission also directed the staff to assess the degree to which 
the Agreement States modify their programs as a result of the change in 
compatibility category and to analyze any transboundary impacts to 
regulated entities, particularly those operating in multiple 
jurisdictions. If transboundary problems are identified, the staff will 
suggest corrective actions that may be necessary (ADAMS Accession No. 
ML103360262). The Commission also planned to consider proposed updates 
to the Policy Statement on Adequacy and Compatibility of Agreement 
State Programs and associated guidance documents to include both safety 
and source security considerations in the determination process. The 
NRC closed PRM-31-5 because all of the petitioners' requests had been 
    As previously discussed, the NRC is denying this portion of the 
petitioner's request because the compatibility of Sec.  31.6 was 
recently and thoroughly addressed in the response to PRM-31-5, and the 
NRC is not aware of any new

[[Page 56841]]

information that would cause it to reevaluate this decision.

III. Conclusion

    The NRC is denying PRM-32-7 because the petition did not present a 
need for any revision of the regulations to add a general license for 
installation and servicing of exempt devices. The petition failed to 
present any significant new information or arguments that would warrant 
the requested amendment. The NRC elected not to request public comment 
on PRM-32-7 because no new regulation is necessary to accomplish the 
petitioner's request; accordingly, there were no public comments on 
this petition.
    As to the additional request for a compatibility change for 10 CFR 
31.6, the issues concerning this categorization were considered and 
addressed by the Commission in a recent decision (77 FR 3640; January 
25, 2012). The Commission will not reconsider that decision at this 
time in the absence of new information that warrants the requested 
    For the previously cited reasons, the NRC is denying PRM-32-7.

    Dated at Rockville, Maryland, this 10th day of September 2013.

    For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 2013-22464 Filed 9-13-13; 8:45 am]